UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027072
Receipt number R000028112
Scientific Title Clinical usefulness of instantaneous wave-free ratio for evaluation of coronary artery lesion with prior myocardial infarction
Date of disclosure of the study information 2017/04/21
Last modified on 2020/01/10 20:33:04

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Basic information

Public title

Clinical usefulness of instantaneous wave-free ratio for evaluation of coronary artery lesion with prior myocardial infarction

Acronym

iFR-OMI

Scientific Title

Clinical usefulness of instantaneous wave-free ratio for evaluation of coronary artery lesion with prior myocardial infarction

Scientific Title:Acronym

iFR-OMI

Region

Japan


Condition

Condition

ischemic heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to investigate the clinical usefulness of iFR in coronary artery lesions with prior myocardial infarction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The optimal iFR cut-off against the clinical FFR cut-off of 0.80 in coronary artery lesions with prior myocardial infarction

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with stable angina pectoris performed diagnostic coronary angiogram and physiological assessment with iFR and FFR

Key exclusion criteria

1) previous coronary bypass grafting
2) hemodialysis
3) lesion of pMI without myocardial viability assessed with echocardiogramphy or cardiac magnetic resonance imaging (MRI)
4) clinical history of MI with non-target legion
5) chronic total lesion
6) tandem lesion; a major native coronary artery with >=2 stenoses separated by a more normal segment.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tairo
Middle name
Last name Kurita

Organization

Mie University Graduate School of Medicine

Division name

Department of Cardiology and Nephrology

Zip code

514-8507

Address

2-174 Edobashi, Tsu 514-8507, Japan

TEL

059-231-5021

Email

k_siho_yuu@hotmail.com


Public contact

Name of contact person

1st name Fukuoka
Middle name
Last name Shusuke

Organization

Mie University Graduate School of Medicine

Division name

Department of Cardiology and Nephrology

Zip code

514-8507

Address

2-174 Edobashi, Tsu 514-8507, Japan

TEL

059-231-5021

Homepage URL


Email

nrh27260@yahoo.co.jp


Sponsor or person

Institute

Department of Cardiology and Nephrology, Mie University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology and Nephrology, Mie University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Mie University Graduate School of Medicine Ethics comittee

Address

2-174 Edobashi, Tsu 514-8507, Japan

Tel

059-232-1111

Email

s-kenkyu3@mo.medic.mie-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 21 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S2352906719301484?via%3Dihub

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S2352906719301484?via%3Dihub

Number of participants that the trial has enrolled

200

Results

In pMI lesions, an iFR cut-off of 0.89 was optimal against a clinical FFR cut-off of 0.80 according to receiver oper- ating characteristics (ROC) curve analysis, whereas in non-pMI lesions, the iFR cut-off value was 0.92 without statistical significance. I

Results date posted

2020 Year 01 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Two-hundred consecutive patients with stable coronary artery disease (CAD) who underwent diagnostic coronary angiogram and physiological assessment with iFR and FFR were retrospectively enrolled from 4 hospitals in Japan from May 2014 and July 2016.

Participant flow

The patients were divided into two groups according to the presence or absence of pMI.

Adverse events

None

Outcome measures

The optimal iFR cut-off against the clinical F FR cut-off of 0.80 in coronary artery lesions with prior myocardial infarction

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 11 Month 10 Day

Date of IRB

2018 Year 09 Month 28 Day

Anticipated trial start date

2016 Year 11 Month 10 Day

Last follow-up date

2018 Year 10 Month 04 Day

Date of closure to data entry

2018 Year 10 Month 05 Day

Date trial data considered complete

2018 Year 10 Month 31 Day

Date analysis concluded

2019 Year 01 Month 10 Day


Other

Other related information

no special instruction


Management information

Registered date

2017 Year 04 Month 20 Day

Last modified on

2020 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028112


Research Plan
Registered date File name
2019/04/21 研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/01/10 データ.xlsx